The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Concussion, Brain Clinical Trial

Official title:

The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170856
• Other study ID #: P00024907
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

Description:

There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 1, 2021
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

Inclusion Criteria:

• Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment

• Low or moderate cardiac risk according to American College of Sports Medicine

• Post-Concussion Symptom Scale (PCSS) score greater than 9

Exclusion Criteria:

• History of neurological surgery

• Seizure disorder

• Use of medication or medical device that would alter heart rate, blood pressure or autonomic function

• Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity

• Unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Concussion, Mild
• Concussion, Severe
• Exertion; Excess

Intervention

Other:
• Sub-maximal exercise
Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28. — View Citation

Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7. — View Citation

Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26. — View Citation

Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225. — View Citation

Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.	Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.	Measured at initial visit and 8-weeks.
Primary	Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.	Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).	The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Secondary	End-tidal CO2	Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.	Measured at initial visit and 8-week post injury visit.
Secondary	Heart Rate	Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.	Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.
Secondary	Volume of Self-reported Exercise Per Week	Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.	Average volume of exercise (min) that was self-reported by participants over the 8-week study period.
Secondary	Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.	Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.	Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic